Trial Outcomes & Findings for Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes (NCT NCT04440449)
NCT ID: NCT04440449
Last Updated: 2022-05-24
Results Overview
1. Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: "Do you feel full of energy?" "No" scored a 1 (exhausted). 2. SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1. 3. SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1 4. Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak). 5. 10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty
COMPLETED
NA
20 participants
Baseline to 6 months
2022-05-24
Participant Flow
The control group did not recruit any subjects due to the COVID-19 pandemic
Participant milestones
| Measure |
Behavioral Lifestyle Intervention
This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
0
|
|
Overall Study
COMPLETED
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Behavioral Lifestyle Intervention
This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
Baseline characteristics by cohort
| Measure |
Behavioral Lifestyle Intervention
n=18 Participants
This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 Years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
—
|
71.5 Years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
—
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
—
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
—
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
—
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: The control group did not recruit any subjects due to the COVID-19 pandemic
1. Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: "Do you feel full of energy?" "No" scored a 1 (exhausted). 2. SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1. 3. SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1 4. Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak). 5. 10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=18 Participants
The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
|---|---|---|
|
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
Baseline
|
1.61 score on a scale
Standard Deviation 1.15
|
—
|
|
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
6 months
|
0.94 score on a scale
Standard Deviation 0.94
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The control group did not recruit any subjects due to the pandemic
Change in HbA1c measured over the study period
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=18 Participants
The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
|---|---|---|
|
Glycated Hemoglobin (HbA1c)
Baseline
|
6.95 Percentage of glycated hemoglobin
Standard Deviation 0.84
|
—
|
|
Glycated Hemoglobin (HbA1c)
6 months
|
6.75 Percentage of glycated hemoglobin
Standard Deviation 0.95
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The control group did not recruit any subjects due to the COVID-19 pandemic
The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows: Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds. * 1 point if held for 10 seconds * 0 points if not held for 10 seconds or not attempted Semi-tandem stand: person attempts to stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds. * 1 point if held for 10 seconds * 0 points if not held for 10 seconds or not attempted Tandem stand: person attempts to stand with the heel of one foot in front of and touching the toes of the other foot for about 10 seconds. * 2 points if held for 10 seconds * 1 point if held for 3 to 9.99 seconds * 0 points if held for \<3 seconds or not attempted
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=18 Participants
The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
|---|---|---|
|
Short Physical Performance Battery (SPPB) Balance
Baseline
|
3.39 score on a scale
Standard Deviation 0.78
|
—
|
|
Short Physical Performance Battery (SPPB) Balance
6 months
|
3.89 score on a scale
Standard Deviation 0.47
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Group B did not recruit any subjects due to the COVID-19 pandemic
Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows: * 0 points if unable to do the walk * 1 point if time is more than 8.70 sec * 2 points if time is 6.21 to 8.70 sec * 3 points if time is 4.82 to 6.20 sec * 4 points if time is less than 4.82 sec
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=18 Participants
The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
|---|---|---|
|
SPPB Gait Speed
6 months
|
3.72 score on a scale
Standard Deviation 0.57
|
—
|
|
SPPB Gait Speed
Baseline
|
3.61 score on a scale
Standard Deviation 0.61
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Group B did not recruit any subjects due to the COVID-19 pandemic
Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows: * 0 points if unable to complete 5 chair stands or completes stands in \>60 seconds * 1 point if chair stand time is 16.70 sec or more * 2 points if chair stand time is 13.70 to 16.69 sec or more * 3 points if chair stand time is 11.20 to 13.69 sec * 4 points if chair stand time is 11.19 sec or less
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=18 Participants
The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Lifestyle App: A mobile app used to assist with lifestyle changes
|
Group B - Control Group
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
|
|---|---|---|
|
SPPB Chair Stands
Baseline
|
2.28 score on a scale
Standard Deviation 1.27
|
—
|
|
SPPB Chair Stands
6 months
|
2.44 score on a scale
Standard Deviation 1.04
|
—
|
Adverse Events
Behavioral Lifestyle Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place